Clinical Studies

Thank You

Caldera would like to acknowledge and thank all the men who have generously participated in our studies. Without your interest and assistance, the company couldn’t have completed the studies listed below. In addition, Caldera have worked with many urologists, nurses, histopatholgists and laboratory staff from around NZ and overseas to complete these studies and we want to also say thank you for all your assistance.

 

Clinical Study 1: Completed in 2014

In Clinical study 1, RNA was extracted from stored formalin-fixed, paraffin-embedded (FFPE) prostatectomy tissue which 42 donors consented to allow Caldera to study. All FFPE blocks were reviewed by an Auckland Hospital histopathologist who identified cancerous and healthy areas for analysis.

Using the our proprietary RBAS system we measured the levels of gene transcripts determining if they were either elevated or diminished in prostate cancer prostatectomy samples as compared to healthy tissue. Significant differential expression could be detected in 60 of our 84 screened biomarkers.

From these 60 RNA biomarkers, the 35 best performing biomarkers were chosen to go forward in the next clinical study.

 

 Clinical Study 2: Completed in 2016

Clinical study 2 compared prostate biopsy tissue without evidence of cancer with tumour tissue isolated from positive biopsies to identify gene signatures able to determine the presence of prostate cancer.

The 35 biomarkers selected in CS1 were used in this study. By examining these on a total of 142 tissue samples, a lead gene signature was identified comprising seven genes and having a sensitivity of 92% and specificity of 95%. As there were multiple very accurate gene signatures, 20 biomarkers able to form multiple gene signatures were selected for the validation study.

 

 Clinical Study 2B: Completed in 2016

Clinical study 2B consisted of: an initial independent validation on 157 samples and a second, blinded, independent validation on 95 samples.

The first section was completed in August 2016, in which 20 biomarkers were analysed for 157 biopsy samples either from men with no evidence of cancer (negative biopsies) or from tumour tissue isolated from positive biopsies. The results allowed selection of the most accurate diagnostic gene signature with a sensitivity of 98% and specificity of 99%.

In December 2016, the blinded study of 95 additional independent samples was completed. Analysis confirmed the high accuracy of the preferred  diagnostic signature with only 4 misclassifications.

In summary, a total of 252 independent validation samples were analysed and these yielded an overall sensitivity of 97% and specificity of 97% for the diagnosis of prostate cancer.

 

 Clinical Study 3: Started in October 2016

Clinical study 3 encompasses 2 sub-studies: Aoraki, in which Caldera is looking to transfer the gene signatures from CS2b generated on prostate tissue to urine; and Tititea, which involves developing a new gene signature for prognosis which would be able to distinguish men with a diagnosis of indolent disease from those with aggressive prostate cancer. In total, Caldera will recruit 300 donors onto the Aotea study who will donate matched urine and biopsy tissue samples (1:1 ratio of samples with and without prostate cancer) and a further 300 donors onto Tititea who will also donate a matched urine and prostate tissue sample (all samples to have prostate cancer).

 

 Contact

For more information or to register your interest in participating in our current study, please contact Gen Johnston gen.johnston@caldera.co.nz